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Cannabinoid
CBD Oil for Stress Related to COVID-19 (CBDOIL Trial)
Phase 2 & 3
Recruiting
Led By Michael J Telch, Ph.D.
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 5-follow-up
Summary
This trial will compare the effects of CBD isolate, full-spectrum CBD oil, broad-spectrum CBD oil, and placebo oil on reducing stress caused by COVID-19.
Who is the study for?
Adults aged 18-70 with COVID-19 related stress, anxiety, depression, anger, substance use issues or sleep disturbances can join. They must be fluent in English, have internet at home and agree to only use study products for 6 weeks. Pregnant individuals or those with certain medical conditions like liver disease or on specific medications cannot participate.
What is being tested?
The trial is testing the effects of three types of CBD oil (isolate, full spectrum, broad-spectrum) versus a placebo oil on emotional distress caused by COVID-19. Participants will receive one of these treatments randomly and their symptoms will be monitored.
What are the potential side effects?
Potential side effects are not detailed here but could include reactions similar to known CBD responses such as fatigue, changes in appetite or mood swings. Allergic reactions may occur especially if sensitive to coconut oil used as a carrier.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 5-follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 5-follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PROMIS Emotional Distress Index
Secondary study objectives
COVID-19 Coping Self-Efficacy
PROMIS Alcohol Negative Consequences Scale
PROMIS Anger Scale
+4 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: Broad-Spectrum CBD oil 300 mg.Active Control1 Intervention
Nightly oral administration of 300 mg. of Broad-Spectrum CBD Oil for 28 consecutive days
Group II: Full-Spectrum CBD Oil 300 mg.Active Control1 Intervention
Nightly oral administration of 300 mg. of Full Spectrum CBD Oil for 28 consecutive days
Group III: CBD-Isolate 300 mg.Active Control1 Intervention
Nightly oral administration of 300 mg. of CBD-Isolate for 28 consecutive days
Group IV: Placebo OilPlacebo Group1 Intervention
Nightly oral administration of 300 mg. of Placebo Oil for 28 consecutive days
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Who is running the clinical trial?
University of Texas at AustinLead Sponsor
374 Previous Clinical Trials
85,975 Total Patients Enrolled
Way West WellnessUNKNOWN
SunFlora.IncUNKNOWN
1 Previous Clinical Trials
29 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are willing to complete a brief pre-study 7-day online symptom monitoring log.You are fluent in English.\nYou are allergic to coconut oil.You have tried to harm yourself in the last six months.You agree not to use any CBD products that are not provided by the study during the 6-week study period.You have experienced negative effects from using CBD oil or other CBD products in the past.You must avoid using any non-study CBD products during the 6-week study period.
Research Study Groups:
This trial has the following groups:- Group 1: Broad-Spectrum CBD oil 300 mg.
- Group 2: Placebo Oil
- Group 3: Full-Spectrum CBD Oil 300 mg.
- Group 4: CBD-Isolate 300 mg.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Substance Abuse Patient Testimony for trial: Trial Name: NCT04603781 — Phase 2 & 3
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